Exercise Training Effect in Patients With HF and PEF

Heart Failure Clinical Trial

Official title:

Exercise Training Effect on Quality of Life and Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696486
• Other study ID #: 15.20
• Status: Completed
• Phase: N/A
• First received: February 22, 2016
• Last updated: January 6, 2017
• Start date: November 2015

Study information

• Verified date: January 2017
• Source: MultiCare Health System Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this is to develop and implement a pilot study that will demonstrate the ability to recruit, enroll, retain, conduct exercise training, and collect pre and post outcomes on the effect of exercise training on quality of life (QOL) and exercise capacity in patients with a diagnosis of heart failure with preserved ejection fraction (HFPEF).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Age > 55 years (Interested in capturing mean ages close to age 65 as many HF initiatives are based on this age group and HF development increases with aging).

• Diagnosis of HFPEF stable NYHA Stage II- III with an EF of = 45%

• Stabilized on cardiac medications and post hospitalization > 4 weeks

• Ability to participate in exercise testing and training.

• Referral from Cardiologist or primary care physician.

Exclusion Criteria:

• Unstable Angina

• Uncontrolled diabetes

• Moderate to severe aortic stenosis

• Uncontrolled hypertension Systolic BP>150 mm Hg or Diastolic BP >100 mm Hg

• Valvular heart disease

• Untreated coronary artery stenosis >50%

• Arrhythmias

• Pulmonary disease/COPD

• Dementia or cognitive impairment

• VAD or Transplant planned in next 6 months.

• Current or recent participation in a Cardiac Rehab program within the last six months.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Exercise Training
Study subjects will receive medically supervised aerobic and resistance exercise training for 1 hour per session, 3 times per week for 6 weeks at the Cardiac Rehab center and then transition to home or YMCA partnership based exercise with staff follow-up contact for an additional 3 weeks.

Locations

Country	Name	City	State
United States	MultiCare Health System	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
MultiCare Health System Research Institute	Henry Ford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life (QOL) score pre and post exercise training (ET).		9 weeks	No
Secondary	Change in exercise capacity/tolerance pre and post ET using Cardiopulmonary Exercise Testing.	Symptom limited treadmill testing with expired gas measurement and analysis. Exercise capacity measured as Peak Vo2 (peak exercise oxygen uptake) in ml/min/kg. Continuous monitoring of 12 lead electrocardiogram and blood pressure measured every 2 minutes. Peak Vo2 defined as highest Vo2 value of the last 30 seconds before termination of exercise. Exercise time and peak workload will be measured for exercise tolerance.	9 weeks	No
Secondary	Demonstrated ability to coordinate patient transition from clinic to home or YMCA partnership based exercise program with weekly staff follow-up within the study timeline.		9 weeks	No
Secondary	Capture 90 day hospital readmission data starting with study enrollment date and within the participants' study timeline.		90 days	No